New Treatment for Nocturnal Enuresis in Children

NCT06497647 | Recruiting

• 1 other identifier: Soh-Med-24-06-05MS
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate the role of sulbutiamine in treatment of monosymptomatic nocturnal enuresis in children by using it alone or as a combination therapy with tricyclic antidepressants (imipramine+sulbutiamine).

Conditions

Nocturnal Enuresis in Children

Keywords

treatment of monosymptomatic nocturnal enuresis in children using sulbutiamine

Outcome Measures

Primary Outcomes (1)

• reduction in the number of wet nights .

  A questionnaire which measure the Response to treatment which will be evaluated by the standardization committee of International clildren's continence society (ICCS) as follows : * Complete response : 100% reduction * Partial response : 50% - 99% reduction * Unresponsiveness : 0 - 49% reduction in nocturnal enuresis episodes. this will be measured by a questionnaire that will be written according a calendar fulfilled by the child and his parents with comparison of the number of wet nights each month.

  the number of wet nights will be measured and compared at the end of each month for 3 months using a calendar fulfilled by the child and his parents.

Secondary Outcomes (1)

• determine any side effects of the drugs used in the study

  this will be discussed in the follow up that will be done in each month in the outpatient clinic for 3 months.

Study Arms (3)

group A

ACTIVE COMPARATOR

this group will receive imipramine alone

Drug: Imipramine

group B

ACTIVE COMPARATOR

this group will receive sulbutiamine alone

Drug: Sulbutiamine

group C

ACTIVE COMPARATOR

this group will receive sulbutiamine plus imipramine

Drug: Sulbutiamine; Drug: Imipramine

Interventions

Sulbutiamine DRUG

sulbutiamine will be used by oral route 100 mg daily for 1 month and follow up will be done every 1 month till 3 months. it will be used alone in group B and combined with imipramine in group C

group B; group C

Imipramine DRUG

imipramine will be used by oral route 25 mg daily for 1 month and follow up will be done every 1 month till 3 months. it will be used alone in group A and combined with sulbutiamine in group C

group A; group C

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age : 6 - 18 years old.
• All children diagnosed by Primary monosymptomatic nocturnal enuresis in this age group.

You may not qualify if:

• Secondary nocturnal enuresis (child who has been continent for at least 6 months before the onset of bedwetting ).
• congenital anomalies (Posterior urethral valve , ectopic ureter , ectopia vesica ,…)
• history of previous lower urinary tract surgery (Multiple hypospadias surgeries ,…, )
• neurogenic bladder (as underactive bladder ).and urge incontinence.
• presence of post-void residual urine greater than 20% of functional bladder capacity.
• history or evidence of disorders in other organs such as (cardiovascular system disease), liver , psychological problems , evident allergic reaction to both medication.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag Faculty of Medecine

Sohag, Egypt

RECRUITING

MeSH Terms

Interventions

sulbutiamine; Imipramine

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

loai mohammed abd alhamied, resident

CONTACT

01093873434; loaimohamed519@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident of urology , sohag university hospital

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 12, 2024
• Study Start: March 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: November 1, 2024
• Last Updated: July 12, 2024

Record last verified: 2024-07

Locations

EG (1)